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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K912975
Device Name OPERAND LUBRICATING JELLY
Applicant
General Medical Co.
P.O. Box 237
Prichard Industrial Park
Prichard,  WV  25555
Applicant Contact RICHARD J.MARSHALL
Correspondent
General Medical Co.
P.O. Box 237
Prichard Industrial Park
Prichard,  WV  25555
Correspondent Contact RICHARD J.MARSHALL
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received07/08/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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